The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair
NCT ID: NCT07076069
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
130 participants
INTERVENTIONAL
2025-07-21
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard Pain Regimen Group
Patients will be prescribed the current department-wide postoperative pain protocol as described in the Intervention Description.
Standard of Care Pain Regimen
No preoperative medications. Interscalene block in the preoperative holding area. Alternating Acetaminophen 975mg and Ibuprofen 600mg every 4 hours, with rescue Oxycodone 5mg every 4 hours, as needed
Multimodal Pain Regimen Group
Multimodal pain regimen medications will be prescribed and administered preoperatively in preoperative holding area, intraoperatively during the procedure, and postoperatively as described in the Intervention Description.
Multimodal Pain Regimen
Preoperatively: One dose of Pregabalin 100mg and Celecoxib 400mg along with interscalene block
Intraoperatively: Intravenous Dexamethasone 0.1mg/kg (maximum dose of 8mg), Magnesium 2g, Acetaminophen 1000mg, and local infiltration of 0.5% Ropivacaine 20ml
Postoperatively (Discharge): Acetaminophen 975mg every 4 hours, Meloxicam 7.5mg once per day, Pregabalin 50mg twice per day, Magnesium 400mg once per day, along with rescue Oxycodone 5mg every 4 hours, as needed
Interventions
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Multimodal Pain Regimen
Preoperatively: One dose of Pregabalin 100mg and Celecoxib 400mg along with interscalene block
Intraoperatively: Intravenous Dexamethasone 0.1mg/kg (maximum dose of 8mg), Magnesium 2g, Acetaminophen 1000mg, and local infiltration of 0.5% Ropivacaine 20ml
Postoperatively (Discharge): Acetaminophen 975mg every 4 hours, Meloxicam 7.5mg once per day, Pregabalin 50mg twice per day, Magnesium 400mg once per day, along with rescue Oxycodone 5mg every 4 hours, as needed
Standard of Care Pain Regimen
No preoperative medications. Interscalene block in the preoperative holding area. Alternating Acetaminophen 975mg and Ibuprofen 600mg every 4 hours, with rescue Oxycodone 5mg every 4 hours, as needed
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients not able to have local nerve block
* Patients who underwent previous shoulder surgery on the same side, kindling revision rotator cuff repair
* Patients who are unable to record and verbalize their pain level due to altered mental status
* Patients who are unable to tolerate any of the medications included in the multimodal pain regimen or standard pain regimen due to severe allergies or inability to consume medication
* Patients with history of previously diagnosed alcohol or drug abuse, renal impairment, peptic ulcer disease, and gastrointestinal bleeding
* Patients who are pregnant
18 Years
ALL
No
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ferdinand Chan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Hutchinson Campus
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Jones MR, Viswanath O, Peck J, Kaye AD, Gill JS, Simopoulos TT. A Brief History of the Opioid Epidemic and Strategies for Pain Medicine. Pain Ther. 2018 Jun;7(1):13-21. doi: 10.1007/s40122-018-0097-6. Epub 2018 Apr 24.
Storesund A, Krukhaug Y, Olsen MV, Rygh LJ, Nilsen RM, Norekval TM. Females report higher postoperative pain scores than males after ankle surgery. Scand J Pain. 2016 Jul;12:85-93. doi: 10.1016/j.sjpain.2016.05.001. Epub 2016 May 27.
Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.
Moutzouros V, Jildeh TR, Khalil LS, Schwartz K, Hasan L, Matar RN, Okoroha KR. A Multimodal Protocol to Diminish Pain Following Common Orthopedic Sports Procedures: Can We Eliminate Postoperative Opioids? Arthroscopy. 2020 Aug;36(8):2249-2257. doi: 10.1016/j.arthro.2020.04.018. Epub 2020 Apr 28.
Other Identifiers
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2022-14249
Identifier Type: -
Identifier Source: org_study_id
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